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Clinical Trial Summary

EBV-HLH and CAEBV are both caused by EBV infection, part of them can rapidly lead to a syndrome of severe, life-threatening hyper-inflammation, with poor prognosis. Currently, the most effective treatment remains unknown. This study is trying to evaluate the efficacy and safety of PD-1 monoclonal antibody as a first-line therapy for EBV-HLH and CAEBV.

Clinical Trial Description

Eligible patients who were diagnosed with EBV-HLH or CAEBV, age between 12 and 70 years, were enrolled in this study. All of them need to sign the informed consent first. PD-1 monoclonal antibody 200mg is infused intravenously once for patients whose age >=18 years, or age <18 years but weight >=40kg. While for patients age <18 years, the dose of PD-1 monoclonal antibody is 3mg/kg. Besides, optimal supportive care is necessary. Ruxolitinib and/or low-dose glucocorticoid can be used to reduce inflammation. Cerebrospinal fluid parameters are examined, and methotrexate 15mg combined with dexamethasone will be intrathecal injected without contraindications. Clinical and laboratory indicators are investigated weekly to evaluate the efficacy and toxicity. If patients achieve partial response/complete response within 14 days after PD-1 monoclonal antibody, the clinical observations are stopped. If not, the observation period is prolonged to 21 days. If disease progress at day 21, this study is terminated, and the patient should be transfer to other treatments as soon as quickly. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05039580
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact Xuefeng He, doctor
Phone 86-18914031640
Email [email protected]
Status Recruiting
Phase Phase 4
Start date May 15, 2021
Completion date April 30, 2023

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